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Respitek receives FDA clearance for Bobbi Baby Shield

Respitek, a South Africa-based disposable medical devices maker, has received the US Food and Administration (FDA) clearance for the Bobbi Baby Shield, which is meant to shield against infection post Hypospadias repair surgery.

Meant for post-surgical protection to prevent infections, the Bobbi Baby Shield creates a barrier between the meatus, gland and diaper and keeps out any human waste at the same time.

Respitek CEO Anton Coetzee said, "This approval will inspire confidence in the Paediatric and Urological fraternity for patients who require hypospadias repair as well as for our company and employees."

"Staph infections are one of the risks post hypospadias repair, so there is a need for protection and especially with infants who need diaper changes."

"The Bobbi Baby Shield also protects the male infant for clean circumcision recovery," Coetzee added.

In addition to minimising the infection risk, the Bobbi Baby Shield also creates a physical barrier preventing pressure on the genitals, providing comfort to the child.

One out of every 150 male new borns require hypospadias repair as it could depend on several factors such as maternal diet, exposure to progestins, location, menarche in the mother, low placental weight and maternal age of mother.